SUPPLY CHAIN ARTICLES

  • Multidisciplinary mRNA: What Can We Learn From Other CGTs?

    Overall, there are four high-level best practices/mindsets I proposed during a recent presentation that I believe will be crucial for us to bring some talented RNA therapeutic role models to the forefront. But there is one best practice that I think is worth emphasizing more than the others.

  • FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities

    The FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.

  • Innovations In The Oligonucleotide Supply Chain: Regulatory Considerations For Materials, Manufacturing, And Lifecycle Control

    Oligonucleotide therapeutics have rapidly advanced into late-stage and commercial development, shifting regulatory focus toward the maturity of manufacturing and supply chain control rather than therapeutic novelty. Regulatory success now depends on how effectively sponsors translate innovative chemistries into well-characterized, scalable, and sustainable materials and processes.

  • ARW's ATMP Manufacturing Must-Reads (ST. PATRICK'S DAY EDITION!)

    Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP industry-related topics that you should at least be aware of in the manufacturing facility. Once a month, I compile the articles and industry updates I think are most worthy of your time into an unconventional roundup article.

  • Therapeutic Oligonucleotides: Regulations & Quality Standards

    Oligonucleotides have surfaced in the past few years as promising therapeutic agents to treat diseases such as neurodegenerative disorders, respiratory disorders, cancer, and diabetic retinopathy. This article recaps a recent USP workshop where participants from regulatory agencies, industry, and academia gathered to discuss best practices and perspectives.

  • Picasso, Pick-Up Lines, & Personalized Medicine: mRNA's Path Forward

    Overall, my presentation on what the mRNA industry can learn from the artist Picasso singled out a few specific areas from which I felt our industry could garner greater inspiration and operational prowess. But given how “collaborative” many of these sources of inspiration are, I’ve introduced each of my takeaways with a surprisingly relevant (albeit bad) art-themed pick-up line. After all, if there’s one sector that knows it takes more than one to “tango,” it’s the mRNA industry.

SUPPLY CHAIN VIDEOS

Here, Ethris’ Christan Dohmen and Tune Therapeutics’ Stu Sundseth share their take on the most meaningful strategies for reducing dsRNA production. But this discussion also probes a deeper question: Is dsRNA still the most relevant impurity the industry should be chasing, or should focus shift to other contaminants? 

Explore a state-of-the-art GMP facility focused on CRISPR based Cell and Gene therapies with helping temperature controlled warehouse and multiple synthesis suites.

In this Bioprocess Online Live panel, we discuss the current state of the mRNA supply chain for critical raw materials and manufacturing supplies and where pain points still exist.

Hosted by Cell & Gene Collaborative's Director Anna Rose Welch, ARW on RNA puts a creative spin on the emerging mRNA + RNA therapeutics industry. Here, in Episode 3, Welch explores the similarities that exist between the art of crafting a high quality violin and the upstream process development work mRNA therapeutics experts are performing today to create the most ideal mRNA drug substance.

ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS